A severe problem has existed in the use of surgical sterile gloves, particularly in operating rooms where procedures for maintaining sterility have to be strictly followed. Specifically, the problem is that the surgeon and other operating room personnel must don the sterile gloves without letting the outside surfaces of the gloves or their sterile gowns come into contacts with any nonsterile surface. This is a difficult procedure because, despite vigorious and prolonged scrubbing, the skin of the operating room personnel is not sterile and contact between the outer glove surfaces and the bare hand, wrist and forearm must be avoided. In addition, while the inside surfaces of the glove may be touched, the contact between the skin and the inside surface of the glove should be confined to the portion of the glove as far inward and away from the edge of the cuff as possible. The cuff portion of the glove when the glove has been donned fits over the sleeve of the gown, and, during operation, the gown cuff will often pull out of the glove cuff to some extent, in which case the gown cuff formerly covered by the glove cuff will be exposed. As a result, any contamination that may have been present on the inside of the glove cuff will have been transferred to the gown cuff now exposed and the exposed, contaminated surface may come into contact with body tissue within the surgical wound.
In the present operating room procedure in which several persons must be gloved, a circulating nurse is employed who is not sterile and who will not take part in the sterile procedures. This circulating nurse is charged with responsibility of opening all the sealed packages containing sterile items but which are presumed to be contaminated on the outside. These items include sterile gowns which will be worn by all attending personnel and sterile gloves. All the sealed packages are designed in such a way that the outer envelope of each package may be peeled open and spread in a flat position on the table in such a way that the inner surfaces of the envelope constitute a sterile field which the circulating nurse does not touch. In a sterile glove package, the outer envelope contains inner folded paper wrap, which in turn contains a pair of sterile gloves.
After the circulating nurse has opened the packages, containing the sterile materials, a second nurse referred to as a scrub nurse, who will later assist in handling sterile objects, is gowned with the assistance of the circulating nurse in such a way that the circulating nurse does not touch the outside of the sterile gown. The gown has long sleeves which are tapered to fit snugly around the wrists of the wearer. After being gowned, the scrub nurse proceeds with the self-donning of sterile gloves using either one of two alternative methods, one of which is referred to as the open method and the other is referred to as the closed method.
In the open method, the scrub nurse opens the inner folded wrapper containing the sterile gloves to expose the gloves lying side by side. The gloves are packaged with a considerable portion of the cuff turned over on itself. The scrub nurse grasps the right glove with her left hand near the folded edge of the cuff portion while maintaining the area of contact between her left hand and the glove as far away as possible from the edge of the cuff. The nurse then inserts her right hand into the glove attempting full entry of the fingers into the tightly fitting glove by tugging with her left hand on the folded over cuff portion. Care must be taken at this point to avoid premature snapping back or unfolding of the cuff portion. To avoid this occurrence, the thumb of the hand being gloved may be hooked into the folded over cuff portion until full entry is made into the finger portion. The folded cuff portion is then unfolded and allowed to snap back along the wrist portion of the hand over the cuff. In carrying out the unfolding of the cuff, care must be taken to avoid touching the outer glove surface and confining contact to the inner surface as far away as possible from the cuff edge. At the same time, care must be exercised to make sure that the left hand of the scrub nurse does not touch the sterile gown cuff. This step of unfolding the cuff of the first glove is an extremely critical point in the open method and it is believed by operating room personnel that contamination occurs more than fifty percent of the time during this step of the procedure. Once the right hand is gloved, the left glove is picked up with the gloved right hand by inserting the gloved hand into the folded cuff portion of the glove. Becaue the outside surface of the glove on the gloved hand is sterile, contact between the gloves' outer surfaces is permitted. The left glove is pulled on by the gloved hand exerting pressure inside of the folded cuff portion and the cuff is unfolded and allowed to snap back along the wrist portion and over the left gown cuff. At this point, care must again be taken to avoid premature unrolling of the glove cuff to avoid contamination of the edge of the cuff that would result from contact with the skin at the wrist portion.
The high incidence of glove contamination which occurs in the open method has led to the adoption in some operating room of the closed method of donning the gloves. The closed method, while lessening the chance of contamination of the gloves, imposes a difficult and almost acrobatic technique upon the scrub nurse who must don the gloves without assistance. In the closed procedure, as in the open method, the scrub nurse is already gowned with the gown having full length tapered sleeves over which the cuff portions of the gloves will be snapped. In this method, instead of grasping the right glove with the bare fingers, the nurse grasps the glove through the gown sleeves. To carry out this technique, the nurse does not put her hands through the sleeve openings, but lets the gown sleeves cover her hands. The scrub nurse grasps the right glove in her left hand through the sleeve and positions the glove over her right wrist with the glove fingers pointing up the arm. Then, still working with her left hand through the left gown sleeve and with her right hand still inside the right sleeve, the nurse inserts the right sleeve cuff into the right glove cuff and snaps the right glove cuff over the right sleeve cuff. Then the nurse grasps the right sleeve cuff, now covered by the glove cuff, with the left hand still working through the left sleeve and pulls the right glove onto the right hand until as much entry into the fingers as can be achieved is effected. The process is then duplicated for the left hand except that the nurse does not work on the left glove through the right sleeve. The nurse, however, must maintain the ungloved left hand inside the sleeve until the left glove is snapped around the left sleeve cuff. The closed procedure is very difficult and requires a lot of practice to develop any proficiency in the procedure.
The above described procedures are concerned with the self-donning of the gloves the the scrub nurse and must be undertaken in order to provide a sterile nurse who can assist the others in the operating room in donning their gloves.
In assisting the donning of a second person, the scrub nurse, who is already gloved, picks up a sterile glove and places the fingers of both hands inside the folded over cuff portion exerting outward pressure in an attempt to stretch open the opening presented to the person to be donned. The donner, often the surgeon, then vigorously thrusts his hand up and into the glove. The nurse must maintain a steady force against this thrust by the surgeon who is attempting an initial thrust to gain access to the fingers of the glove. Almost in the same motion, the nurse thrusts forward and, by letting go of the glove cuff at the right moment, attempts to cause the cuff to snap over the surgeon's gown cuff without any rollover of the cuff edge.
Because of the difficulty in fully inserting hands into the gloves, the inner surface of the gloves must be heavily powdered to lubricate the glove surface relative to the hands. This powder in operation normally results in powder getting on the external surfaces of the glove. As a result, the surgeon must use sterile wipes to cleanse the glove surfaces of powder because the presence of powder particles in a surgical wound would aggravate the internal organs and tissue and would adversely affect healing following surgery.
While sterile gloves are necessary in operating rooms, a greater number of sterile gloves are used in procedures outside of operating rooms. Usually outside of the operating rooms, the person donning the glove must don the gloves without assistance. In many of these instances, a gown is not used, so the person donning the glove has no alternative but to use the open method of donning with its attendant greater risks of accidental contamination. In these instances, the contamination often occurs when attempts are made to prevent the cuff from rolling or in straightening out a cuff that has rolled over.
While the procedures an requisites, described above, necessary to avoid contact with unsterile surfaces are strictly required, in actual practice, accidents of contamination have been commonplace.
The invention described in application Ser. No. 819,842 provides a sterile glove package which permits the sterile glove to be donned quickly, easily, without assistance while maintaining the sterility of the glove surface and without any powder appearing on the outside of the glove. The glove is packaged with a ring and a flexible liner covering the outside surface of the glove. The liner extends through the ring with the edge of the liner folded over the outside of the ring. The glove extends through the middle of the ring inside of the liner and the cuff of the glove is stretched around the outside of the ring with the edge of the cuff extending back in toward the middle of the ring so that the cuff defines a round opening through which the material of the liner and the hand and the finger portion of the glove extend. The ring of the package thus holds the cuff of the gloves open for insertion of the hand into the glove.
With the above described package, the gloves can be donned very easily and with little danger of the outside glove surfaces coming into contact with the contaminated surface and also contact of the inside of the cuff of each glove and contaminated surfaces can be completely avoided except where the glove comes into contact with the wrist of the person wearing the glove beyond the end of the gown sleeve. The liner covering the outside surface of the glove provides a convenient microbial barrier through which the glove can be manipulated during the donning procedure to maintain the surface of the glove sterile. Moreover, because the liner covers the outside surface of the glove, the inside surface of the glove can be powdered with lubricating, moisture absorbing powder without any of the powder getting on the outside surface of the glove in contrast with present day packages in which powder is always all over the outside of the gloves as well as inside the gloves.